The Effect of a Low FODMAP Diet in Functional Dyspepsia Patients With Meal Related Symptoms (FFD)

The Effect of a Low FODMAP Diet in Functional Dyspepsia Patients With Meal Related Symptoms (Postprandial Distress Syndrome According to the Rome IV Consensus)

In this study, the investigators will evaluate the FODMAP diet as an alternative treatment for functional dyspepsia and explore its effect on different aspects of the pathophysiology of FD.

Study Overview

• Status: Completed
• Conditions: Functional Dyspepsia; FODMAP Diet
• Intervention / Treatment: Other: low FODMAP diet

Detailed Description

The study design starts with a baseline period of 2 weeks, includes 6 weeks of a 'strict' FODMAP diet (no blinded), followed by a 9 week 'reintroduction' phase (single blind). Based on the patients' symptom results following each of these challenges, patients will then follow the 'moderate' FODMAP diet, where the FODMAPs that did not trigger any symptoms during the challenge tests can now be consumed. Finally patients follow 2 weeks of a diet 'moderate' in FODMAP levels (no blinded). Blood and stool samples will be collected during the complete trial at several timepoints. In addition, before and after the strict diet phase a gastroscopy will be performed as well as an intragastric pressure measurement and breath test.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • KU Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• patients with functional dyspepsia (postprandial distress syndrome)
• written informed consent
• 18-70 years

Exclusion Criteria:

1. Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for entry into the study
2. Patients with any major psychiatric disorders (including those with a major psychosomatic element to their gastrointestinal disease), depression, alcohol or substance abuse in the last 2 years
3. Patients presenting with predominant symptoms of irritable bowel syndrome (IBS) and of gastro-oesophageal reflux disease (GERD)
4. Patients who changed their diet over the last 3 months or have previously tried the low FODMAP diet are excluded from the study.
5. Females who are pregnant or lactating are excluded from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: low FODMAP diet	Other: low FODMAP diet; strict low FODMAP diet followed by reintroduction of different FODMAPs and glucose (control)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement on gastrointestinal symptoms	The primary endpoint is to evaluate the efficacy of low FODMAP diet on gastrointestinal symptoms in FD. Based on the LPDS questionnaire (Leuven Postprandial Distress Syndrome Score), the primary endpoint is defined. This questionnaire contains questions with a scoring system from 0 till maximum 5 with higher scores indicating higher symptom severity. An improvement of 0.5 is considered clinically meaningful.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reintroduction period	Percentage of patients experiencing symptom worsening upon blinded reintroduction of single FODMAPs by means of LPDS daily diaries	2 years
Evaluation of the low FODMAP diet on IBS related symptoms	by IBS-SSS and IBS-QoL questionnares	2 years
Evaluation of the low FODMAP diet on symptom response and quality of life	by PAGISYM and SFNDI questionnaires	2 years
Evaluation of the low FODMAP diet on depression, somatization	by PHQ	2 years
Evaluation of the low FODMAP diet on duodenal barrier function	Duodenal mucosal integrity was evaluated in adapted mini-Ussing chambers and defined by transepithelial electrical resistance (TEER) and paracellular permeability for FITC dextran (macromolecular flux) (4kDa).	2 years
Evaluation of the low FODMAP diet on gastric emptying	The C13-octanoic breath test was used to measure gastric emptying rate.	2 years
Evaluation of the low FODMAP diet on gastric accommodation	Intra-gastric pressure measurement was used to quantify gastric accommodation at baseline and at the end of the low FODMAP diet.	2 years

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2019
• Primary Completion (Actual): March 8, 2022
• Study Completion (Actual): March 8, 2022

Study Registration Dates

• First Submitted: May 6, 2020
• First Submitted That Met QC Criteria: April 24, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia
• Other Study ID Numbers: s61692

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No